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Ken Peh ★ Malaysia, 2013-05-21 21:24 (4766 d 09:41 ago) Posting: # 10612 Views: 5,637 |
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Dear All, When we run a fully replicate design for highly variable drug, may I know how elimination rate constant (ke) and elimination half-life (t1/2) are analyzed statistically ? Same as for AUC ?? What about Tmax ? As Tmax is analyzed statistically using non-parametric test for 2-way crossover design (2x2), I presumed this parameter should also be analyzed the same way for fully replicate design (2x4). The only difference is taking the average of Tmax of test and reference product. Appreciate if could kindly comment on the above. Thank you. Regards, Ken |
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Helmut ★★★   Vienna, Austria, 2013-05-22 22:54 (4765 d 08:11 ago) @ Ken Peh Posting: # 10621 Views: 4,589 |
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Hi Ken! ❝ […] how elimination rate constant (ke) and elimination half-life (t1/2) are analyzed statistically ? Same as for AUC ?? Nobody requires a comparison. Elimination is drug-specific (i.e., does not depend on the formulation). Just report the means ± SD (geometric – or harmonic, if you want to split hairs). ❝ What about Tmax ? As Tmax is analyzed statistically using non-parametric test for 2-way crossover design (2x2), I presumed this parameter should also be analyzed the same way for fully replicate design (2x4). The only difference is taking the average of Tmax of test and reference product. Wait until the draft will be finalized: No statistical comparison required any more.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Ken Peh ★ Malaysia, 2013-05-23 13:44 (4764 d 17:21 ago) @ Helmut Posting: # 10627 Views: 4,506 |
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Dear Helmut, Thank you very much for your input. ❝ Wait until the draft will be finalized: No statistical comparison required any more. May I know which guideline ? FDA ? Regards, Ken |
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Helmut ★★★ Vienna, Austria, 2013-05-23 14:03 (4764 d 17:02 ago) @ Ken Peh Posting: # 10628 Views: 4,565 |
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Hi Ken! ❝ ❝ Wait until the draft will be finalized: No statistical comparison any more. ❝ May I know which guideline ? The ASEAN draft GL Section 3.1.8 states “A statistical evaluation of tmax is not required.” ❝ FDA ? tmax is not required for ages. FDA wants partial AUC truncated at the median tmax of the reference as metric of early exposure. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz